Professional Documents
Culture Documents
Metrax Primedic Defi-N - User Manual PDF
Metrax Primedic Defi-N - User Manual PDF
1. Safety instructions 26
2. Device Specification 27
The PRIMEDIC™ Defi-N M100 27
The PRIMEDIC™ Defi-B M110 29
3. Preliminary measures 31
3.1 Loading the rechargeable batteries (only Defi-B) 31
6. Waste treatment 36
8. Conditions of Guarantee 41
9. Appendix 42
A1 General instructions and rules for the handling of defibrillators 42
A2 Voltage - time graphs 44
A3 Safety control 46
19621 / 05.02 25
™
PRIMEDIC Defi-N / Defi-B Instructions for use
1. Safety instructions
The following has to be considered in order to ensure safe and perfect function of the PRIMEDIC™
Defibrillators and to avoid risk to human beings and other material property:
1. Any use of the PRIMEDIC™ Defibrillators requires the knowledge and strict compliance of these
instructions for use.
2. The PRIMEDIC™ Defibrillators are designed and suitable exclusively for the applications set out
or described in this manual. Using the device for purposes any other than those mentioned in
this manual may constitute a risk and has to be omitted.
3. Operation of the PRIMEDIC™ Defibrillators, as well as basically all other defibrillators, in areas
subject to explosion hazards is not allowed.
4. The PRIMEDIC™ Defibrillators may only be used by trained and authorised personnel. Reading
the instructions for use does not replace any training.
5. Any repair work, modifications, additions and installations of the PRIMEDIC™ Defibrillators may
only be carried out by personnel authorised and trained by METRAX. The parts of the
PRIMEDIC™ Defibrillators may not be repaired by the user.
6. The device may only be used with accessories, wearing parts and disposable parts the secure
use of which is proofed by an inspection office authorised to tests of devices ready-to-use.
Otherwise a safe and reliable function of PRIMEDIC™ Defibrillators is not guaranteed. The
original PRIMEDIC™ accessories and wearing parts comply with this condition.
7. Before using the device the user has to check that the device is in a safe and reliable state. If
e.g. the defibrillator cable is damaged the defibrillator may not be used.
8. The instructions and rules set out in appendix A1 have to be complied with when using the
PRIMEDIC™ Defibrillators.
9. The unit must be under operating conditions before using.
10. The PRIMEDIC™ Defi-N is not suitable for use outdoors.
11. Do not use the PRIMEDIC™ Defibrillators near devices (e.g. measuring devices) sensible to
magnetic fields or disturbing sources, which could interfere with the functions of PRIMEDIC™
Defibrillators. Keep sufficient distance.
12. Do not charge more than 15 times at maximum energy. The number of discharges should not
exceed 3 per minute. Afterward, allow the unit to cool down for an extended period of time.
Additionaly the national regulations for the use of medical devices are applicable.
26 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
2. Device Specification
8 9 1 2 3
1 Carrying handle
2 Release button
3 Paddle right (APEX)
4 Paddle cable
5 Defibrillator unit with operating elements
6 Mains plug
7 Paddle cable
8 Paddle left
9 Release button
19621 / 05.02 27
™
PRIMEDIC Defi-N / Defi-B Instructions for use
20
21
22
23
24
25
26
28 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
8 9 1 2 3
1 Carrying handle
2 Release button
3 Paddle right (APEX)
4 Paddle cable
5 Defibrillator unit with operating elements
6 Mains plug
7 Paddle cable
8 Paddle left
9 Release button
19621 / 05.02 29
™
PRIMEDIC Defi-N / Defi-B Instructions for use
27 28 29
20
21
22
23
24
25
26
30 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
3. Preliminary measures
The appliance can be kept on standby both in a horizontal
and an upright position.
Defi-N: Insert mains plug in socket in the vicinity of
ergometer. The mains cable has a length of 3 m, thereby
permitting a corresponding operating radius emergiencies.
Defi-B: With the integrated rechargeable accumulator you are
independent of a power source.
Note:
In case that the defibrillators are operated from a timer (e.g.
night disconnection) it may not be uninterruptedly connected
to this socket. Otherwise the reconnecting of the power
supply will cause a renewed charging procedure. This can
cause damage to the battery due to over charging.
19621 / 05.02 31
™
PRIMEDIC Defi-N / Defi-B Instructions for use
32 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
Attention:
If the Attention LED (26) is still on after switching off and on
again, the malfunction must be eliminated immediately.
19621 / 05.02 33
™
PRIMEDIC Defi-N / Defi-B Instructions for use
34 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
19621 / 05.02 35
™
PRIMEDIC Defi-N / Defi-B Instructions for use
6. Waste treatment
The packing of the unit should be used for recycling. The
metal parts of the unit will be processed by the metal-scrap
recycling. Plastic parts, electronic components and relais
plates will be processed by the electronic scrap.
Accumulators should be separated and given to your local
recycling company. Do not include them within your normal
waste. For further information, please contact your local
recycling company.
36 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
Defibrillation:
Operating mode: asynchronous, external defibrillation
Energy steps: 20, 50, 100, 160, 250, 360 joule (50 Ω)
Charging time: approx. 9 s (360 Joule) with 230 V / 50 Hz
Paddle: Paddle for children integrated
Safety Classification: Protection type II, Type BF, Medical device class 2b
0123
Other data:
Nominal main circuit: see rating plate
Operating conditions: 0 ... 40 °C, 30 ... 95 % rel. humidity, but without condensation
700 hPa ... 1060 hPa
Storage environment: -20 ... 70 °C, 20 ... 95 % rel. humidity, but without condensation
500 hPa ... 1060 hPa
Dimensions: 40 x 48 x 12 cm (w x d x h)
Weight: 8,5 kg
Subject to alterations.
Delivery specification:
Part no.
™
1 PRIMEDIC Defi-N 90426
consists of:
1 Conductive gel, 60 g 13026
1 Medical device protocol 13084
1 Instructions for use 19621
1 Briefing protocol 18514
Accessories
Part no.
Bag with two transparent storage compartments 14467
Conductive gel, 60 g 13026
19621 / 05.02 37
™
PRIMEDIC Defi-N / Defi-B Instructions for use
Defibrillation:
Operating mode: asynchronous, external defibrillation
Energy steps: 20, 50, 100, 160, 250, 360 joule (50 Ω)
Charging time: approx. 7 s (360 Joule)
Paddle: Paddle for children integrated
Safety Classification: Protection type II, Type BF, Medical device class 2b
0123
Other data:
Power supply: by accumulator 14,4 V / 1,5 Ah
Nominal voltage: see rating plate
Charging time: 3,5 hours (100 %)
Accumulator capacity: 35 shocks + 10 in reserve (360 Joule)
Operating conditions: 0 ... 40 °C, 30 ... 95 % rel. humidity, but without condensation
700 hPa ... 1060 hPa
Storage environment: -20 ... 70 °C, 20 ... 95 % rel. humidity, but without condensation
500 hPa ... 1060 hPa
Dimensions: 40 x 48 x 12 cm (w x d x h)
Weight: 9 kg
Subject to alterations.
Delivery specification
Part no.
™
1 PRIMEDIC Defi-B 90427
consists of:
1 Conductive gel, 60 g 13026
1 Medical device protocol 13084
1 Instructions for use 19621
1 Briefing protocol 18514
Accessories
Part no.
Bag with two transparent storage compartments 14467
Conductive gel, 60 g 13026
38 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
7.3 Symbols
Rating plate:
Protection type II
Degree of protection BF
Paddle / Casing:
Danger
19621 / 05.02 39
™
PRIMEDIC Defi-N / Defi-B Instructions for use
Operating elements:
Charge energy
Place paddles
Discharge energy
Give shock
System error!
Defibrillation impossible!
40 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
8. Conditions of Guarantee
As the manufacturer, METRAX grants a guarantee on this device for 2 years starting with the date of
purchase. During this period, METRAX will eliminate any defects in the device, resulting from material
faults or manufacturing faults, free-of-charge. Elimination of defects is made by METRAX either by
repair or by replacement. Any repair carried out during the guarantee period shall not extend the
original guarantee period.
The right to claim under guarantee and damage claims provided by law do not apply in case of only
immaterial impairment of usefulness, natural wear or damages, produced after liability transfer to the
buyer, as a result of wrong or negligent use, excessive stress or caused by extreme external influences
not covered by the terms of agreement. The same applies if the buyer or third parties perform
modifications or repair work in an unprofessional manner.
Further contractual and non-contractual claims against METRAX are excluded unless such claims are
based on intent or on severe negligence or on compelling liability regulations provided by law.
Claims for damages by the buyer against the seller (trader) remain unaffected by this guarantee.
In case of claims under guarantee, you are asked to send the device including a buyer’s certificate (e.g.
a bill), stating your name and address, to your dealer or to METRAX.
The METRAX-customer service will be glad to assist you even after the guarantee period has expired !
19621 / 05.02 41
™
PRIMEDIC Defi-N / Defi-B Instructions for use
9. Appendix
What is a defibrillator ?
During defibrillation current is delivered to the heart muscle. The contraction caused and the
depolarization of the heart muscle eliminate dangerous cardiac irregularity.
Cardiac irregularity means uncoordinated electric and mechanical activities of the heart muscle.
The a. m. table shows two general groups of cardiac irregularity and the possible counter-measures.
PRIMEDIC™ defibrillators Defi-N and Defi-B are designed for assynchronious defibrillation,
therefore synchronious cardioversions are not possible.
The procedure of the two cardioversions are different and described in the following:
1. Unsynchronized defibrillation:
With this procedure energy is released immediately as soon as the keys for "shock release" are
pressed. This procedure requires the clear and definite establishment of the diagnosis "ventricular
flutter or pulse missing".
Asynchronous supply of energy to the cardiac rhythm by the defibrillator can cause damages to the
heart. If the energy is supplied to the heart muscle during the ventricular refractory period (approx. first
half of the T-wave) the heart is susceptible to ventricular fibrillation.
42 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
19621 / 05.02 43
™
PRIMEDIC Defi-N / Defi-B Instructions for use
Please find in the following the graph shapes of the defibrillation pulses depending on the terminal
resistance.
U = 2.280 V 2 ms / div.
U = 2.940 V 2 ms / div.
44 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
U = 3.180 V 2 ms / div.
U = 2.800 V 2 ms / div.
19621 / 05.02 45
™
PRIMEDIC Defi-N / Defi-B Instructions for use
A3 Safety control
According to Medizinprodukte Betreiberverordnung (MPBetreibV) § 6 (safety controls) users of
defibrillators are obliged to have the devices controlled. According to MPBetreibV § 6 METRAX has
prescribed controls in 12 month cycles.
The safety controls must be carried out only by persons qualified by their training, their knowledge and
experience gained in practice to execute controls professionally and not receiving any instructions for
the controls. They also must dispose of the appropriate measure- and test instruments.
If the safety control reveals any defect that represents a hazard for patients, employees or third parties,
the responsible authority has to be informed immediately by the user according to MPBetreibV § 3.
In accordance with MPBetreibV § 7 the following data has to be entered in the medical device
protocol accompanying the device:
• Time when the work was carried out
• Name of the person or company who/which carried out the work and
• the work carried out.
METRAX can be held responsible for the contents of the operating manual only. This especially applies
to new settings, commissioning and modifications to the device.
In the rotational control the following work and checks have to be undertaken by a service technician:
1. Check whether the device shows external damages
• Casing deformed?
• Paddle cable damaged?
• Mains plug damaged
• Paddle damaged?
• Paddle for adults available and attached?
• Rating plate on the back of the device legible?
2. Check whether operating elements are damaged
• Release buttons damaged?
• Mains switch dust-cover damaged?
• Mains switch and rocker are in order?
• Membrane keyboard legible?
• Membrane keyboard damaged?
3.1 Display Elements Defi-N
• Check the LEDs in the membrane keyboard:
• The LED allocated to the selected energy step lights up (check all energy steps once).
• After pressing the load key (24), the according LED (23) must illiuminate.
• Check the acoustic warning signals.
3.2 Display Elements Defi-B
• One of the LED’s on the accumulator status display must light up when unit is turned on.
• Check the LED’s in the membrane keyboard for proper function:
• The LED allocated to the selected energy step lights up (check all energy steps once).
• After pressing the load key (24), the according LED (23) must illuminate.
• Check the acoustic warning signals.
4.1 Measure the charging time Defi-N
• Switch off device - and switch it on again.
• Press the key 360 Joule (22).
• Press the load key (24) while concurrently switching on the stop-watch.
At 230 V / 50 Hz supply voltage the charging time should not exceed 9 seconds.
At 200 V / 50 Hz supply voltage the charging time should not exceed 14 seconds.
4.2 Measure the charging time Defi-B
• Switch off device - and switch it on again.
• Press the key 360 Joule (22).
• Press the load key (24) while concurrently switching on the stop-watch.
• With the accumulator fully charged, the charging time may not exceed 7 seconds.
• After 15 defibrillations with 360 joules, loading takes only slightly longer.
46 19621 / 05.02
™
Instructions for use PRIMEDIC Defi-N / Defi B
19621 / 05.02 47